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Fusion Pharmaceuticals Inc. (Nasdaq: FUSN) is a clinical-stage oncology company based in Hamilton, Ontario, Canada, and Boston, focusing on the development of next-generation radioconjugates (RCs) for precision cancer treatments. The company specializes in targeted alpha therapy (TAT), leveraging their unique expertise in linking alpha particle-emitting isotopes to targeting molecules to create highly effective therapeutics.
Fusion’s lead program, FPI-2265, is designed specifically for metastatic castration-resistant prostate cancer (mCRPC). This innovative treatment targets the prostate-specific membrane antigen (PSMA) and is currently undergoing a Phase 2 clinical trial. FPI-2265 aims to improve patient outcomes by delivering a potent radioactive payload directly to cancer cells, minimizing damage to healthy tissues. The recent Phase 2 TATCIST trial results, presented at the AACR Annual Meeting 2024, demonstrated promising clinical activity and safety, with meaningful improvements in secondary endpoints for mCRPC patients.
Fusion’s pipeline includes several other promising candidates, such as FPI-1434, targeting the insulin growth factor 1 receptor (IGF1R), FPI-2059, targeting the neurotensin receptor 1 (NTSR1), and FPI-2068, a bispecific IgG-based RC targeting EGFR-cMET.
The recent acquisition of Fusion by AstraZeneca marks a significant milestone. AstraZeneca will acquire all of Fusion’s outstanding shares for $21.00 per share in cash, plus a non-transferable contingent value right of $3.00 per share, subject to achieving specific regulatory milestones. This acquisition, valued at approximately $2.4 billion, underscores Fusion's pivotal role in pioneering RCs and enhancing AstraZeneca's oncology portfolio.
Fusion operates a state-of-the-art Good Manufacturing Practice (GMP) compliant facility, ensuring the production of clinical doses for its expanding pipeline. The company has strategic actinium supply agreements with Niowave, Inc., and BWXT Medical to meet the growing demand for their therapies.
With a robust pipeline, strategic partnerships, and a strong balance sheet, Fusion is well-positioned to advance their mission of transforming cancer treatment through innovative alpha-emitting radioconjugates.
Fusion Pharmaceuticals (Nasdaq: FUSN) announced the appointment of Dr. Philina Lee to its Board of Directors. Dr. Lee, with over 15 years of biopharmaceutical experience, was previously head of U.S. marketing for Algeta, known for the first alpha-emitting radiopharmaceutical. CEO John Valliant emphasized her experience in precision oncology and commercial launch strategies as vital during the company's growth. The board size increased from seven to eight members, enabling more robust strategic planning for Fusion's Targeted Alpha Therapies platform, which aims to advance cancer treatments.
Fusion Pharmaceuticals (Nasdaq: FUSN) has initiated the multi-dose portion of its Phase 1 study for FPI-1434, a radioimmunoconjugate targeting IGF-1R in advanced solid tumors. The initial single-dose phase showed FPI-1434 was well-tolerated, without dose-limiting toxicities or serious adverse events. The multi-dose trial aims to assess safety, tolerability, and pharmacokinetics, with initial doses set at 75kBq/kg. This study is pivotal for understanding the therapeutic potential of FPI-1434 and will influence the Phase 2 design.
Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company, will present at the Jefferies Virtual London Healthcare Conference on November 19, 2020, at 8:30 AM EST. The presentation will feature CEO John Valliant, CFO John Crowley, and CMO James O'Leary. Attendees can access a live webcast on the company's website, with a replay available for 90 days. Fusion focuses on developing next-generation radiopharmaceuticals, using its proprietary Fast-Clear linker technology to target tumors selectively. The lead program, FPI-1434, is currently undergoing a Phase 1 clinical trial.
Fusion Pharmaceuticals (FUSN) reported Q3 2020 financial results, revealing cash reserves of $303.1 million, enabling operations through 2024. The Phase 1 trial of FPI-1434 is on track, with multi-dosing expected Q4 2020, supported by safety data from previous cohorts. Notably, a collaboration with AstraZeneca aims to advance next-generation radiopharmaceuticals, retaining commercial rights for existing products. However, the company reported a net loss of $10.0 million for Q3 2020, indicating challenges in profitability amidst increased R&D and G&A expenses.
Fusion Pharmaceuticals (Nasdaq: FUSN) has appointed Barbara Duncan as the new chairperson of its board of directors, succeeding Damian Lamb. Duncan brings over 25 years of biopharmaceutical experience, notably as the former CFO of Intercept Pharmaceuticals. CEO John Valliant emphasized that her extensive industry knowledge and leadership would help enhance Fusion's standing in the radiopharmaceutical sector, particularly as the company advances its Targeted Alpha Therapies platform and grows its pipeline. Duncan also holds positions on several other biopharmaceutical boards.
Fusion Pharmaceuticals Inc. (Nasdaq: FUSN) announced the appointment of Maria Stahl as the new chief legal officer, effective immediately. With extensive legal experience in the biopharmaceutical industry, Stahl's leadership is expected to aid in advancing the company's lead candidate and expanding its development pipeline. CEO John Valliant emphasized the importance of her strategic guidance during this critical growth phase. Fusion's lead program, FPI-1434, is currently undergoing a Phase 1 clinical trial, reflecting the company’s focus on developing next-generation radiopharmaceuticals.
Fusion Pharmaceuticals Inc. (Nasdaq: FUSN) will participate in a fireside chat at the Morgan Stanley Virtual 18th Annual Global Healthcare Conference on September 17, 2020, at 11:00am EDT. The presentation will feature CEO John Valliant, CFO John Crowley, and CMO James O'Leary. Investors can access the live webcast on the company's website, with a replay available for 90 days. Fusion specializes in developing next-generation radiopharmaceuticals using Fast-Clear linker technology, with its lead program FPI-1434 in Phase 1 clinical trials.
Fusion Pharmaceuticals Inc. (Nasdaq: FUSN) reported its financial results for Q2 2020, highlighting a cash position of $318.9 million, enough to fund operations into 2024. The net loss for the quarter was $44.7 million, driven by non-cash charges related to Class B preferred shares. Fusion is progressing in its Phase 1 clinical trial of FPI-1434, expecting safety and imaging data by Q4 2020, while COVID-19 has created uncertainties for timelines. The company achieved significant financing milestones and aims to expand its targeted alpha therapies pipeline.
Fusion Pharmaceuticals (Nasdaq: FUSN) announced that CEO John Valliant, Ph.D., will present a company overview at the 2020 Wedbush PacGrow Healthcare Virtual Conference on August 12, 2020, at 9:10 AM EDT. The presentation will be available via a live webcast on the company's website, with a replay accessible for 90 days thereafter. Fusion is focused on developing next-generation radiopharmaceuticals using its proprietary Fast-Clear linker technology to target tumors with alpha particle emitting isotopes. Its lead program, FPI-1434, is currently in Phase 1 clinical trials.
Fusion Pharmaceuticals Inc. (NASDAQ: FUSN) has priced its initial public offering (IPO) at $17.00 per share, offering 12,500,000 common shares. The total gross proceeds are expected to reach $212.5 million before deductions. The IPO will begin trading on the Nasdaq Global Market on June 26, 2020, with closure anticipated by June 30, 2020. Underwriters have a 30-day option to purchase an additional 1,875,000 shares. Morgan Stanley, Jefferies, and Cowen are managing the offering, which aims to advance Fusion's clinical-stage oncology pipeline focusing on radiopharmaceuticals.
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